Automatic portable glove tester

Ensure glove integrity in critical environments with rapid, precise leak testing, safeguarding aseptic conditions without disrupting operations.

Performs Leak and Integrity Testing on Gloves

The Speedy Glove from Comecer is a portable glove integrity tester designed to meet the rigorous demands of pharmaceutical and radiopharmaceutical environments. This system is unique due to its rapid inflation feature, shortening test duration by up to 30%. It operates without connection to pneumatic circuits, making it ideal for isolators in aseptic processes, containment processes, and radiopharmaceutical production. The Speedy Glove tester, compatible with all glove flange types, ensures precise leak and integrity testing using a pressure decay method compliant with ISO 14644-7 Annex E.5. It supports real-time pressure monitoring and avoids unnecessary isolator downtime by enabling both inside-to-outside and reverse testing. The device features RFID technology for accurate test traceability and CFR Part 11 compliant data handling, storing up to 1,000 test reports. Its battery-powered, Wi-Fi-ready design integrates easily within existing production lines, contributing to enhanced operational efficiency and compliance with cGMP standards.

Benefits

  • Saves time with a rapid inflation system, reducing test duration by 30%.
  • Enhances safety and compliance in critical environments with precise detection of glove leaks.
  • Increases operational efficiency by enabling continuous workflow without isolator downtime.
  • Ensures regulatory compliance with ISO 14644-7 and CFR Part 11 standards.
  • Facilitates traceable testing, minimizing human error with RFID technology.

General


Applications
Aseptic processes,Containment processes,Active pharmaceutical ingredients (api),Radiopharmaceuticals,Highly active pharmaceutical ingredients (hapi)
End products
Antiviral medications,Hormonal medications,Controlled release tablets,Immunotherapy drugs,Diagnostic radiotracers,Oncology drugs,Therapeutic radiopharmaceuticals,Sterile injectable medications
Steps before
Isolator setup,Glove installation,Pressure stabilization,Pre-production qualification
Steps after
Post-production qualification,Decontamination,Battery recharging,Report generation
Input ingredients
gloves for testing,air for inflation,RFID tags,power (battery)
Output ingredients
leak test report,glove integrity status,CSV files,PDF files
Market info
Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.

Technical Specifications


Automation
Automatic
Battery-powered
Yes
Pressure decay integrity tests
Yes
RFID technology
Yes
Wi-Fi ready
Yes
VPHP compatibility
Yes
Rack charging
Yes
Compatibility
All glove flanges on the market
Inflation system
Rapid inflation
Inflation direction
Inside to outside / Outside to inside
Report storage
1,000 reports
Battery recharge time
4 hours

Operating Characteristics


Glove integrity testing mode
Pressure decay test
Testing speed
3-5 minutes faster per test
Automation level
Automatic / Manual
Testing direction
Inside to outside / Outside to inside
Decontamination compatibility
VPHP (Vaporised Hydrogen Peroxide)
Use environment
Aseptic / Containment processes

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Product type Characteristics


Glove flange compatibility
All currently available glove flanges

Physical Characteristics


Device portability
Battery-powered
Touch-screen interface
Complete touch-screen

Custom Options


Control panel type
Touch-screen
Integration possibilities
Wi-Fi ready,RFID technology
Flexibility in mounting
Compatible with all glove flanges
Decontamination compatibility
VPHP compatible
Portability
Battery powered
Charging method
Rack charging